3d打印-现代医疗保健的革命:最近的成就与挑战

IF 0.3 Q4 PHARMACOLOGY & PHARMACY
A. Thakkar, Anshul Chaudhary, Samiksha
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引用次数: 0

摘要

制药行业每年都在增长,将公众健康作为优先事项、保护和经济发展。该行业主要集中在新药开发过程以及有助于提高病情恢复率和提高患者治疗质量的新方法上。制药公司最近尝试使用3D打印生产药物,以提高质量并改善用户健康。后来,在2015年,这些公司通过生产3D打印药物Spritam获得了成功,该药物已获得美国食品药品监督管理局的批准。在过去的几年里,医疗器械行业已经适应了3D打印技术,创意公司利用它生产出具有独特内容、外观和可定制性的产品。然而,3D打印的这些独特功能给监管机构接受这些设备带来了新的法律困难和令人不安的问题。通过3D打印技术打印的医疗设备的可定制性和独特的施工程序在实现制造的质量保证和监管标准方面存在困难。3D打印技术的进步有助于生产各种创新的医疗产品以及新的结构和成分。本综述讨论了美国食品药品监督管理局以及其他监管机构在批准3D打印产品时面临的独特监管问题,以及制定3D打印设备安全、质量和有效性法规所需的措施。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
3d Printing – A Revolution In Modern Healthcare: Recent Achievements & Challenges
The pharmaceutical industry grows every year keeping public health as a priority, protection, and economic development. The industry is mostly concentrated on the novel drug development process as well as new methods that can help improve the recovery rate of a condition and improve the quality of patient treatment. Pharmaceutical companies have recently experimented with producing medications using 3D printing to increase their quality and improve user health. Later, in 2015, the companies found success by producing the 3D-printed medication Spritam, which had already received US FDA approval. Over the past few years, the medical device industry has adapted to 3D printing technology and creative companies have used it to produce goods with distinctive content, appearance, and customizability. However, these distinctive capabilities of 3D printing have brought forth new legal difficulties and troubling issues with the regulatory agencies' acceptance of these devices. Customizability and distinctive construction procedures of medical devices printed via 3D printing techniques have difficulties in attaining quality assurance and regulatory criteria for manufacturing. Advancement in 3D printing technology has helped in the production of various innovative medical products along with new structures and constituents. The present review discusses distinctive regulatory problems faced by the USFDA as well as by other regulatory authorities in the case of approval of 3D printing products and measures required to develop regulations for the safety, quality, and effectiveness of 3D printing Devices.
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来源期刊
Current Drug Therapy
Current Drug Therapy PHARMACOLOGY & PHARMACY-
CiteScore
1.30
自引率
0.00%
发文量
50
期刊介绍: Current Drug Therapy publishes frontier reviews of high quality on all the latest advances in drug therapy covering: new and existing drugs, therapies and medical devices. The journal is essential reading for all researchers and clinicians involved in drug therapy.
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